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FDA 510(k) Application Details - K140296
Device Classification Name
More FDA Info for this Device
510(K) Number
K140296
Device Name
CLEARLUMEN THROMBECTOMY SYSTEM
Applicant
WALK VASCULAR, LLC
17171 DAIMLER STREET
IRVINE, CA 92614 US
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Contact
BRAD CULBERT
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Regulation Number
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Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2014
Decision Date
12/02/2014
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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